OR Manager

Vol. 23 No. 10
October 2007

Sterilization & Infection Control

Using biological indicators

appropriately

iological monitoring is the cornerstone of your sterilization quality assurance

B
cators?
program. What’s the right way to use biological indicators (BIs)? What’s their
role in load release? And how are they used in conjunction with chemical indi-

OR Manager posed frequently asked questions to Cynthia Spry, RN, MA, MSN,
CNOR, cochair of the working group that recently issued a comprehensive update to
the steam sterilization standard from the Association for the Advancement of Medical
Instrumentation (AAMI). The new edition of the Comprehensive Guide to Steam Sterili-
zation and Sterility Assurance in Health Care Facilities (ANSI/AAMI ST79) was published

Q
in Fall 2006.
What is the difference between a biological and a chemical indicator?
Why do we need to use both?
Spry: Sterilization indicators, which are actually quality monitors, pro-
vide information to let you know a sterilizer is working as it should be. They also
give some assurance that the sterilization process has been appropriate and safe for
the patient.
BIs and chemical indicators (CIs) both give important information. A sterilization
cycle has certain parameters that must be achieved for sterilization to occur, such as
a specific temperature that must be reached for a specific amount of exposure time.
A BI, which contains live organisms with a known resistance to the sterilization
process, is the only monitor that measures the lethality of the sterilization process.
In contrast, a CI tests whether one or more parameters within the sterilizer have
been met or missed. The easiest example is a Class 1 CI, which simply tells you
there’s been exposure to the sterilant.
The key concept is that all of these indicators have different purposes—one is not
better than the other. CIs give you results immediately. BIs must be incubated to see
if the spores germinate and grow, which, depending on the type used, can take a sig-
nificant amount of time. Most facilities do not have enough instrument inventory to
hold their items until the BI incubates. CIs can give some assurance that the items
are probably sterile. If all indicators produce the results they are supposed to pro-
duce, there is a probability, though it is a high probability, that your items are sterile.
But remember: No matter what happens with these indicators, they do not guar-
antee that the items in the sterilization load have become sterile. It’s the whole
process, including decontamination, cleaning, pack preparation, sterilization, and

Q
quality monitoring, that determines whether the items in a load will be sterile.
What is the difference between using the conventional BI and the
early readout BI? I have heard they are now considered equivalent. Is
that correct?
Spry: They are both BIs. There is not a special category for early readout
BIs. The early readout BI provides a result based on an enzyme reaction and pro-
vides results in a relatively short time. The early readout BI also contains spores, and
you can choose to incubate it if you want additional information. Users like the early
readout BI because the enzyme readout and the fully incubated readout are highly
correlated—if one is negative, the other should also be negative.
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 Sterilization process monitoring
recommendations
Routine load release
Nonimplants Implants

Physical monitoring of cycle Physical monitoring of cycle

External and internal chemical External and internal chemical

monitoring of packages monitoring of packages

Optional monitoring of the load Monitoring of every load with:

with a process challenge device • a PCD containing a BI and a
(PCD) containing one of the Class 5 integrating indicator or
following:
• a PCD containing a BI and an
• a biological indicator (BI) enzyme-only indicator.
• a BI and a Class 5 integrating
indicator
• a BI and an enzyme-only
indicator
• a Class 5 integrating indicator
• an enzyme-only indicator.

Note: A process challenge device is an item designed to constitute a

defined resistance to a sterilization process and used to assess peformance
of the process.
Source: Association for the Advancement of Medical Instrumentation. Comprehensive
Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.
ANSI/AAMI ST 79: 2006, p 81. Section of Table 7. Reprinted with permission.

For reassurance, most facilities elect to grow out the early readout BI from time
to time. It is up to the facility to determine how often to do this. Some do it every
time they run a load; others do it occasionally. The AAMI standard is not prescrip-

Q
tive about how often to do this. It’s up to the user to confer with the manufacturer
to determine how to use the product.

What is AAMI’s recommend-ation on using BIs for routine load release?

Spry: You don’t have to use a BI for routine load release in a load that
doesn’t contain an implant—it’s optional. AAMI says optional monitoring of a non-
implant load includes a PCD (process challenge device) with one of the following:
• a BI
• a BI and a Class 5 integrating indicator
• a BI and an enzyme-only indicator
• a Class 5 integrating indicator
• an enzyme-only indicator.
Though monitoring is optional, it’s common practice for facilities to monitor with
a BI often. One issue is that if you have a recall, you must go back to your last neg-
ative BI. If you haven’t done any monitoring with a BI in a while, you may have a
lot of loads that you will need to recall. So monitoring more often is better than less
often.
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 OR Manager
Vol. 23 No. 10

Q
October 2007

What is the recommendation for monitoring loads with implants?

Spry: If you have a load with implants, use of a BI is not optional. AAMI
recommends that every load with an implant be monitored with a PCD containing:
• a BI and a Class 5 integrating indicator or
• a BI and an enzyme-only indicator.
Both AAMI and AORN strongly recommend that you should not release an
implant until results of the BI are known.
The benefit of using the Class 5 indicator or an enzyme-only indicator is that you get
some information immediately. A Class 5 integrating indicator is a very good tool. I per-
sonally think it would be nice to use a Class 5 in every pack because it gives you much
more information than a Class 1 indicator. But a Class 5 integrator is more expensive
than a Class 1 indicator, so many hospitals use a Class 1 rather than a Class 5 in every

Q
pack.
What if a surgeon insists on having an implant released before the BI
result is known?
Spry: AAMI has very strong wording to say that releasing implants
before the BI results are known is unacceptable and should be the exception, not the
rule. AAMI recommends developing a guidance defining emergency situations and
taking steps to reduce the frequency of these emergencies. If there is an emergency,
and an implant must be released before the BI results are known:
• The release should be documented.
• The BI result obtained later should also be documented.
• The documentation should be fully traceable to the patient, for example, by
recording the sterilizer load number on the patient chart or recording the patient
name on the load record.
AAMI provides a sample form for documenting these exceptions (Annex L).
Exceptions should be reviewed to see if there are patterns. Why did this happen?
How often does it happen? Is it occurring in a particular specialty or with a particu-

Q
lar surgeon? Then look at the patterns to see what needs to be corrected to prevent
these situations.
Does AAMI define an implant?
Spry: AAMI refers to the Food and Drug Administration’s definition,
which says an implant is a device placed into a surgically or naturally formed cavi-
ty of the human body that is intended to remain there for a period of 30 days or
more. By that definition, orthopedic screws would be implants, and processing of
these is a major concern of mine. I know not all facilities process screws as if they are
implants. I have seen some flash sterilized, which is specifically not recommended
for implants.
In some instances, a screw that has been on the table but not used is placed back in
the rack, and the rack is flash sterilized without proper decontamination. I think peo-
ple need to think about their practice in this regard. I would also like to see these screws
supplied sterile from the manufacturer. I remember a time when hip prostheses were

Q
routinely processed in the hospital. Now they are commercially sterilized. I would like
to see the same thing for all plates and screws.
What does AAMI recommend for biological testing of steam sterilizers?
Spry: AAMI suggests doing routine sterilizer efficacy monitoring weekly,
preferably daily, with a full load, using a PCD containing a BI. The PCD may also

Q
contain a CI. In flash sterilizers, monitoring is done in an empty chamber.
Can you suggest any tools we can use to help educate the staff about
AAMI’s monitoring recommendations?
Spry: Get the AAMI ST79 standard and turn to pages 81-82. There you
will find Tables 7 and 8, which summarize the monitoring recommendations. These
tables tell you specifically what monitoring to do for load release and for efficacy
testing of your sterilizers. You’ll want to keep them handy for easy reference. 3
Sterilization today requires a significant knowledge base. It used to be we had
 OR Manager
Vol. 23 No. 10
October 2007

only steam and ethylene oxide. Now we have not only steam but different kinds of
steam; we have hydrogen peroxide, gas plasma, and liquid sterilization. Instruments
are also much more complex, we know more about infection, and we know the
implications of infections with implants.
You should not be operating a sterilizer or processing instruments unless you’re
clear about what needs to be done and what kind of indicator is appropriate. Users
really need to stay on top of this. v
The AAMI ST79 standard is available from AAMI at http://marketplace.aami.org/. The
price is $200 ($100 for AAMI members).

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